Back to resultsCompare the Clinical Efficacy of Prototype Toothpastes
Primary Purpose
Dental Plaque
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluoride
Triclosan, fluoride
Metal salt
Sponsored by
About this trial
This is an interventional treatment trial for Dental Plaque
Eligibility Criteria
Inclusion Criteria:
- Male or female volunteers 18-65 years of age.
- Good general health.
- Must sign informed consent form.
- Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
- No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
Exclusion Criteria:
- Subject unable or unwilling to sign the informed consent form.
- Medical condition which requires pre-medication prior to dental visits/procedures.
- Moderate or advanced periodontal disease.
- 5 or more decayed untreated dental sites at screening.
- Other disease of the hard or soft oral tissues.
- Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
- Use of medications that currently affect salivary flow.
- Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
- Pregnant or nursing women.
- Participation in any other clinical study within 1 week prior to enrollment into this study.
- Use of tobacco products.
- Subjects who must receive dental treatment during the study dates.
- Current use of Antibiotics for any purpose.
- Presence of an orthodontic appliance.
- History of allergy to common dentifrice ingredients.
- History of allergy to zinc.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
Sites / Locations
- Concordia Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Fluoride control -A
Triclosan/Fluoride - B
Triclosan/fluoride/metal salt- C
Arm Description
Winterfresh Gel
Positive control (Total toothpaste)
test toothpaste
Outcomes
Primary Outcome Measures
Plaque Index
Plaque Index score scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Gingivitis Index
Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Secondary Outcome Measures
Full Information
NCT ID
NCT00926029
First Posted
September 26, 2008
Last Updated
February 16, 2012
Sponsor
Colgate Palmolive
1. Study Identification
Unique Protocol Identification Number
NCT00926029
Brief Title
Compare the Clinical Efficacy of Prototype Toothpastes
Official Title
Compare the Clinical Efficacy of Prototype Toothpastes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluoride control -A
Arm Type
Placebo Comparator
Arm Description
Winterfresh Gel
Arm Title
Triclosan/Fluoride - B
Arm Type
Active Comparator
Arm Description
Positive control (Total toothpaste)
Arm Title
Triclosan/fluoride/metal salt- C
Arm Type
Experimental
Arm Description
test toothpaste
Intervention Type
Drug
Intervention Name(s)
Fluoride
Other Intervention Name(s)
Colgate Winterfresh Gel
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Triclosan, fluoride
Other Intervention Name(s)
Colgate Total toothpaste
Intervention Description
Brush twice daily
Intervention Type
Other
Intervention Name(s)
Metal salt
Other Intervention Name(s)
New toothpaste formula being evaluated.
Intervention Description
Brush twice daily
Primary Outcome Measure Information:
Title
Plaque Index
Description
Plaque Index score scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Time Frame
6 weeks
Title
Gingivitis Index
Description
Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female volunteers 18-65 years of age.
Good general health.
Must sign informed consent form.
Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
Exclusion Criteria:
Subject unable or unwilling to sign the informed consent form.
Medical condition which requires pre-medication prior to dental visits/procedures.
Moderate or advanced periodontal disease.
5 or more decayed untreated dental sites at screening.
Other disease of the hard or soft oral tissues.
Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
Use of medications that currently affect salivary flow.
Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
Pregnant or nursing women.
Participation in any other clinical study within 1 week prior to enrollment into this study.
Use of tobacco products.
Subjects who must receive dental treatment during the study dates.
Current use of Antibiotics for any purpose.
Presence of an orthodontic appliance.
History of allergy to common dentifrice ingredients.
History of allergy to zinc.
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salim A Nathoo, DDS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Concordia Clinical Research
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
07927
Country
United States
12. IPD Sharing Statement
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Compare the Clinical Efficacy of Prototype Toothpastes
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